An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)

Psoriasis Clinical Trial

— CIMPASI-1  

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326298
• Other study ID #: PS0005
• Secondary ID: 2014-003513-28
• Status: Completed
• Phase: Phase 3
• Start date: December 16, 2014
• Est. completion date: October 24, 2018

Study information

• Verified date: October 2019
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol in adults with moderate to severe chronic plaque psoriasis when administered every 2 weeks.

Description:

This study consists of the following Periods:

• Initial Treatment Period from Week 0 to Week 16

• Maintenance Treatment Period from Week 16 to Week 48

• Open-label Treatment Period from Week 48 to Week 144

• Safety Follow-Up Period from Week 144 to Week 152

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: October 24, 2018
• Est. primary completion date: March 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provided informed consent

• Adult men or women >= 18 years

• Chronic plaque psoriasis for at least 6 months

• Baseline psoriasis activity and severity index >= 12 and body surface area >= 10 % and Physician's Global Assessments score >= 3

• Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy

• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Erythrodermic, guttate, generalized pustular form of psoriasis

• History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol

• Congestive heart failure

• History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease

• Concurrent malignancy or a history of malignancy as described in the protocol

• History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis)

• Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 5 months following last dose of study drug (in Czech Republic and Germany) and within 3 months for all other countries. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose of study drug

• Any other condition which, in the Investigator's judgment, would make the subject unsuitable for participation in the study

• Other protocol-defined exclusion criteria may apply

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Biological:
• Certolizumab Pegol
Active Substance: Certolizumab Pegol Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 200 mg/mL Route of Administration: Subcutaneous use

Other:
• Placebo
Active Substance: Placebo Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 0.9 % saline Route of Administration: Subcutaneous use

Locations

Country	Name	City	State
Canada	Ps0005 596	Ajax	Ontario
Canada	Ps0005 595	Drummondville	Quebec
Canada	Ps0005 597	Edmonton	Alberta
Canada	Ps0005 590	Hamilton	Ontario
Canada	Ps0005 594	Quebec City	Quebec
Canada	Ps0005 591	Surrey	British Columbia
Canada	Ps0005 593	Toronto	Ontario
Czechia	Ps0005 553	Nachod
Czechia	Ps0005 550	Olomouc
Czechia	Ps0005 551	Ostrava-Poruba
Czechia	Ps0005 552	Praha 10
Germany	Ps0005 560	Berlin
Germany	Ps0005 561	Dresden
Germany	Ps0005 563	Hamburg
Germany	Ps0005 568	Hamburg
Germany	Ps0005 566	Kiel
Germany	Ps0005 569	Lubeck	Schleswig-Holstein
Germany	Ps0005 562	Mahlow	Brandenburg
Germany	Ps0005 565	Witten	Nordrhein-Westfalen
Hungary	Ps0005 582	Budapest
Hungary	Ps0005 580	Orosháza	Bekes
Hungary	Ps0005 581	Pecs
United States	Ps0005 507	Albuquerque	New Mexico
United States	Ps0005 500	Baton Rouge	Louisiana
United States	Ps0005 506	Boston	Massachusetts
United States	Ps0005 501	Houston	Texas
United States	Ps0005 508	Nashville	Tennessee
United States	Ps0005 505	Saint Louis	Missouri
United States	Ps0005 504	San Diego	California
United States	Ps0005 502	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Hungary, 

References & Publications (1)

Gottlieb AB, Blauvelt A, Thaçi D, Leonardi CL, Poulin Y, Drew J, Peterson L, Arendt C, Burge D, Reich K. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, pl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16	The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	At Week 16
Primary	Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16	The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.	At Week 16
Secondary	Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16	The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	At Week 16
Secondary	Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16	The DLQI is a subject-reported questionnaire designed for use in adult participants with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asks participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than of equal to (>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL).	At Week 16
Secondary	Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48	The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0= clear, 1= almost clear, 2= mild, 3= moderate, 4= severe.	At Week 48
Secondary	Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48	The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	At Week 48

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